MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH UNITRAX V40 SLEEVE +4MM; IMPLANT

Catalog Number 6942-6-070

Device Problem Device Slipped (1584)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 08/04/2014

Event Type  malfunction  

Event Description

Endo sleeve would not stay seated on the trunion.After several attempts were made the decision was made to open another implant.

Manufacturer Narrative

A supplemental report will be submitted upon completion of the investigation.

Manufacturer Narrative

Implant, explant date updated.An event regarding assembly issues involving a unitrax sleeve was reported.The event was not confirmed.Device evaluation and results indicated that the device was not returned for evaluation.Medical records were not received for review.Device history review.The reported device was manufactured into final stock with no reported discrepancies.Complaint history review.There have been no other events for the reported lot.The exact cause of the event could not be determined as the device was not available for evolution.No further investigation for this event is possible at this time.

Event Description

Endo sleeve would not stay seated on the trunion.After several attempts were made the decision was made to open another implant.

• Brand Name: UNITRAX V40 SLEEVE +4MM
• Type of Device: IMPLANT
• Manufacturer (Section D): STRYKER ORTHOPAEDICS-MAHWAH; 325 corporate drive; mahwah NJ 07430
• Manufacturer (Section G): STRYKER ORTHOPAEDICS-MAHWAH; 325 corporate drive; mahwah NJ 07430 NA
• Manufacturer Contact: niku kasmai ; 325 corporate drive; mahwah, NJ 07430 ; 2018315000
• MDR Report Key: 4045042
• MDR Text Key: 4728946
• Report Number: 0002249697-2014-03279
• Device Sequence Number: 1
• Product Code: KWL
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K954077
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Health Professional
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 08/05/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/28/2014
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 03/31/2019
• Device Catalogue Number: 6942-6-070
• Device Lot Number: 47156503
• Other Device ID Number: STER. LOT 1603GCM
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 09/29/2014
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 03/11/2014
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 77 YR
• Patient Weight: 69